BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Berkeley VC-10 Vacuum Curettage System

    K Number: K171440 · Decision Sep 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    136

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    Basic Information

    Device Name
    Berkeley VC-10 Vacuum Curettage System
    K Number
    K171440
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5070
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Acmi
    Date Received
    May 16, 2017
    Decision Date
    September 29, 2017
    Product Code
    HHI
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HHI System, Abortion, Vacuum

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